This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior ... more>>
This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to... ... more>>
This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. more>>
The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and... ... more>>
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products... ... more>>
This presentation will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's... ... more>>
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11.... ... more>>
This webinar will greatly help medical device industry and relevant professionals establish and maintain adequate design control procedures. more>>
FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485 require Risk Management as integral part of the development life cycle. The... ... more>>
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint... ... more>>
This webinar demystifies Part 11 and the new European equivalent Annex 11. It gets you on the right track for using electronic records and signatures ... more>>
This course will teach you how to reduce software validation costs by as much as two thirds. It details all the requirements for 21 CFR Part 11 and... ... more>>
This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal... ... more>>